Observation Study of the Medication Switch at Patients Treated With Sitaxentan to a Regime Without Sitaxentan

NCT ID: NCT01281371

Last Updated: 2013-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-06-30

Brief Summary

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Due to the withdrawal of Thelin (Sitaxentan) in December 2010 all patients with pulmonary hypertension treated with Sitaxentan need to be switched to an alternative therapy. This study will observe in which way the change of medication - in the clinical routine, without exception in charge of the treating physician - affects clinical and laboratory parameters and patient's quality of life.

Detailed Description

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Conditions

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Hypertension, Pulmonary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Pulmonary hypertension
* Treatment with Sitaxentan

Exclusion Criteria

* Inability or unwillingness to give written informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Department of Clinical Pharmacology and Pharmacoepidemiology

Principal Investigators

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Walter E. Haefeli, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology and Pharmacoepidemiology

Locations

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Department of Clinical Pharmacology and Pharmacoepidemiology, Medical department of the University of Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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K344

Identifier Type: -

Identifier Source: org_study_id

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